Growth and Nutritional Biomarkers of Preterm Infants Fed a New Powdered Human Milk Fortifier: A Randomized Trial
Autor: | Amandine Rubio, Laurent Ameye, Jean Michel Hascoët, Bernard Guillois, Elie Saliba, Jonathan Jaeger, Johannes Spalinger, Fabio Mosca, Claude Billeaud, Nicholas P. Hays, Jean Charles Picaud, Umberto Simeoni, M. Radke, Jacques Rigo, Virginie de Halleux |
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Rok vydání: | 2017 |
Předmět: |
Male
0301 basic medicine growth Nutritional Status Weight Gain law.invention 03 medical and health sciences 0302 clinical medicine Double-Blind Method Randomized controlled trial law 030225 pediatrics Outcome Assessment Health Care medicine Humans Infant Very Low Birth Weight low birth weight Food science Infant Nutritional Physiological Phenomena Biomarkers/metabolism Dietary Fats Dietary Proteins Female Food Fortified Infant Care/methods Infant Newborn Infant Premature/growth & development Infant Premature/metabolism Infant Very Low Birth Weight/growth & development Infant Very Low Birth Weight/metabolism Milk Human Nutrition Assessment Outcome Assessment (Health Care) Nutritional biomarkers 030109 nutrition & dietetics business.industry Original Articles: Nutrition Gastroenterology human milk food and beverages Human milk fortifier Docosahexaenoic acid Infant Care Pediatrics Perinatology and Child Health Energy density Nutrition physiology medicine.symptom business Weight gain Biomarkers Infant Premature |
Zdroj: | Journal of pediatric gastroenterology and nutrition, vol. 65, no. 4, pp. e83-e93 Journal of Pediatric Gastroenterology and Nutrition |
ISSN: | 1536-4801 0277-2116 |
DOI: | 10.1097/mpg.0000000000001686 |
Popis: | Objectives: The aim of this study was to assess growth and nutritional biomarkers of preterm infants fed human milk (HM) supplemented with a new powdered HM fortifier (nHMF) or a control HM fortifier (cHMF). The nHMF provides similar energy content, 16% more protein (partially hydrolyzed whey), and higher micronutrient levels than the cHMF, along with medium-chain triglycerides and docosahexaenoic acid. Methods: In this controlled, multicenter, double-blind study, a sample of preterm infants ≤32 weeks or ≤1500 g were randomized to receive nHMF (n = 77) or cHMF (n = 76) for a minimum of 21 days. Weight gain was evaluated for noninferiority (margin = –1 g/day) and superiority (margin = 0 g/day). Nutritional status and gut inflammation were assessed by blood, urine, and fecal biochemistries. Adverse events were monitored. Results: Adjusted mean weight gain (analysis of covariance) was 2.3 g/day greater in nHMF versus cHMF; the lower limit of the 95% CI (0.4 g/day) exceeded both noninferiority (P |
Databáze: | OpenAIRE |
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